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NCT02600507 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
A Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
- 20
- Study locations
NCT02600507 is a Phase 3 study of Bipolar Depression that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 529 participants, above the 198-participant average among 29 other Bipolar Depression trials with a reported enrollment target (167% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT02600507, a Phase 3 study of Bipolar Depression, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone (ITI-007)
Study Locations (20)
California
- Clinical Site - Cerritos
- Clinical Site - Costa Mesa
- Clinical Site - Culver City
- Clinical Site - Garden Grove
- Clinical Site - Glendale
- Clinical Site - Lemon Grove
- Clinical Site - Oceanside
- Clinical Site - Pico Rivera
- Clinical Site - Riverside
- Clinical Site - San Diego
- Clinical Site - Santa Rosa
- Clinical Site - Sherman Oaks
- Clinical Site - Temecula
Florida
- Clinical Site - Jacksonville
- Clinical Site - Lauderhill
- Clinical Site - Miami
- Clinical Site - Orange City
- Clinical Site - Orlando
Arkansas
- Clinical Site - Rogers
Georgia
- Clinical Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02600507
The ClinicalTrials.gov registry entry for NCT02600507 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 198-participant average among 29 other Bipolar Depression trials with a reported enrollment target (167% higher). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02600507 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT02600507 about?
NCT02600507 is a clinical study titled "Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression". The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
What is the current status of trial NCT02600507?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2016-03-07. Estimated completion is 2020-07-02.
What conditions does trial NCT02600507 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT02600507?
The interventions under investigation include: Placebo (DRUG), Lumateperone (ITI-007) (DRUG).
Who is sponsoring clinical trial NCT02600507?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02600507 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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